摘要
目的:改进注射用兰索拉唑有关物质的测定方法。方法:采用反相高效液相色谱(RP-HPLC)法,色谱柱为ShimPack CLC-ODS柱(150mm×4.6mm,5μm),流动相为水-乙腈-三乙胺(60:40:1),用磷酸调节pH值至7.0,稀释样品的混合溶剂为水-乙腈-三乙胺(60:40:1),用磷酸调节pH值至10.0,流速为1.0ml/min,检测波长为285nm。结果:在选定的色谱条件下,主峰和紧邻杂质峰能得到更好的分离。结论:此法结果准确,分离度好,可用于注射用兰索拉唑有关物质的测定。
Objective:To improve the determination of related substances in Lansoprazole for Injection. Methods :A RPHPLC method was established.The chromatographic column was ShimPack CLC-ODS column(150 mm×4.6 mm,5 μm). The mobile phase was water-Acetonitrile-Triethylamine (60:40:1) ,and adjusted pH to 7.0 with phosphoric acid.The solvent was waterAcetonitrile-Triethylamine(60:40:1) ,and adjusted pH to 10.0 with phosphoric acid.The flow rate was 1.0 mL/min ,The determination wavelength was 285 nm. Results :Under this selected chromatograph condition,the prominent peak and the neighbor subsidiary peak could be better separated. Conclusion :This method is accurate,with very good separation effect.It can be used to determine the related substances in Lansoprazole for injection.
出处
《临床医药实践》
2009年第12Z期2273-2275,共3页
Proceeding of Clinical Medicine
